INFANTS GAS RELIEF DYE FREE- simethicone antigas emulsion 
THE KROGER CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kroger INFANTSs GAS RELIEF Dye free DROPS

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Warnings

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
do not exceed 12 doses per day.
Fill enclosed dropper or syringe to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
clean dropper well after each use-recap bottle with original cap
mL = milliliter

Age (yr)

Weight (lb)

Dose (mL)

infants under 2

under 24

0.3

children over 2

over 24

0.6

Other information

tamper evident: do not use if printed seal under cap is broken or missing
store at room temperature
do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Comments or Questions?

855-200-BABY

www.ComfortsForBaby.com

Principal Display Panel

NDC# 30142-171-01

Dye Free Drops

INFANTS’ GAS RELIEF

*compare to the active ingredient of INFANTS’ MYLICON® DROPS

*see the side panel

Dye Free Drops

INFANTS’ GAS RELIEF

SIMETHICONE-ANTIGAS

Non-Staining formula
Gently Breaks Down Baby’s Gas Bubbles
No alcohol
No Artificial Colors or Flavor

1 Fl. OZ (30ml)

100 DOSES

IMPORTANT: Keep this carton for future reference on full labeling

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY INFIRST HEALTHCARE INC., THE DISTRIBUTOR OF INFANTS’ MYLICON® DROPS. INFIRST HEALTHCARE INC. IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

Kroger Infants Gas Relief Drops
INFANTS GAS RELIEF  DYE FREE
simethicone antigas emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-171
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-171-011 in 1 CARTON07/16/2019
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/16/2019
Labeler - THE KROGER CO. (006999528)

Revised: 8/2023
Document Id: c2746ea9-5585-4c9d-a81f-9155a8c604a1
Set id: 722c8226-6556-4150-9fda-91be2b31183f
Version: 5
Effective Time: 20230822
 
THE KROGER CO.